Oral Cancer Clinical Trial
Official title:
Phase III Trial Comparing Conventional RT With Concomitant CT Versus Accelerated RT With Concomitant CT Versus Very Accelerated RT Alone in Patients With Head and Neck Squamous Cell Carcinoma
This is a multicentric randomized phase III trial comparing conventional radiotherapy with concomitant chemotherapy versus accelerated radiotherapy with concomitant chemotherapy versus very accelerated radiotherapy in patients with stage III-IV head and neck squamous cell carcinoma. The main end point is the event free survival.
This is a multicentric randomized phase III trial comparing conventional radiotherapy with
concomitant chemotherapy (arm A) versus middle accelerated radiotherapy with concomitant
chemotherapy (arm B) versus very accelerated radiotherapy alone (arm C) in patients with
stage III-IV head and neck squamous cell carcinoma (HNSCC). The main end point is the event
free survival.
The treatments are
Bras A : Conventional radiotherapy given once daily, delivering 70 Gy in 7 weeks (5
fractions of 2 Gy per week) and chemotherapy: 5FU : 600 mg/m²/d, Paraplatin : 70 mg/m²/d,
D1-4 and D22-25 and D43-46
Bras B: middle accelerated radiotherapy delivering 70 Gy in 6 weeks and chemotherapy: 5FU :
600 mg/m²/d, Paraplatin : 70 mg/m²/d, D1-5 and D29-33
- first part : radiotherapy given once daily delivering 40 Gy in 4 weeks and 20 fractions
of 2 Gy
- second part : radiotherapy given twice daily with "concomitant boost" delivering 30 Gy
in 20 fractions in 2 weeks (1,5 Gy x 2 / day)
Bras C: very accelerated radiotherapy given twice daily delivering 64.8 Gy in 3.5 weeks in
36 fractions of 1.8 Gy
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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